FDA 510(k)

SPRINT PNS 系统

K号: K202660 · 2021-01-22

决定日期2021-01-22

产品代码NHI

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决定实质等同

器械摘要

SPRINT PNS System is the device name listed in this FDA 510(k) record. The listed applicant is Spr Therapeutics, Inc.. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K202660. The device is classified under product code NHI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SPRINT PNS System?

SPRINT PNS System is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Spr Therapeutics, Inc.. The 510(k) number is K202660.

When did SPRINT PNS System receive FDA 510(k) clearance?

SPRINT PNS System received FDA 510(k) clearance on 2021-01-22, under 510(k) number K202660.

Who is the listed applicant for SPRINT PNS System?

The FDA 510(k) record lists Spr Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPRINT PNS System?

The FDA product code for SPRINT PNS System is NHI.

列明Spr Therapeutics, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K240974SPRINT PNS 系统 K223306SPRINT 周围神经刺激 (PNS) 系统 K211801SPRINT PNS 系统 K181422SPRINT 周围神经刺激系统，Extensa，SPRINT 周围神经刺激系统，Endura，SPRINT 临床编程器套件

官方来源

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